Auxiliary Medicinal Product Dossier (AxMPD)

Auxiliary medicinal product means a medicinal product used for the needs of a clinical trial as described in the protocol, but not as an investigational medicinal product.

Examples are medicinal products used as rescue medication, challenge agents, to assess end-points in the clinical trial, or background treatment. Further, the medicinal product should be related to and relevant for the design of the clinical trial, which excludes ‘concomitant medications’.

Where an AxMP is not authorised, or where an authorised AxMP is modified while such modification is not covered by a marketing authorisation, it shall be manufactured according to Good Manufacturing Practice (GMP) requirements or to at least an equivalent standard, in order to ensure appropriate quality. For unauthorised AxMP an (simplified) AxMPD should be submitted. For authorised AxMP only a valid SmPC should be submitted.